Plantar fasciitis is a painful condition that arises when the plantar fascia under a patient's arch become strained or over-stretched. The condition can be particularly painful after extended rest periods during which the fascia stiffen and tighten. When the patient stands after that rest period, the stiffened fascia are pressed by the force of the patient's weight, causing further pain.
Various devices have been used to treat this condition, typically employing a stiff frontal frame that fits against the front of the patient's leg and extends in an L-shape along the patient's forefoot, being held to the patient by straps that wrap around the patient's leg and foot. An example is the dorsal night splint disclosed in U.S. Pat. No. 5,776,090 to Bergman. The Bergman splint includes a frame held to the anterior side of a patient's lower leg by straps. The frame has stiffening ribs that permit it to hold its shape and is bent, prior to the patient putting it on, so the frame's forefoot and foreleg portions are held at a pre-set angle.
A variation in the Bergman splint is disclosed in U.S. Patent Application Publication No. 2008/0208094 of Gaylord. The Gaylord splint has an adjustable stabilizing frame that is also pre-bent to a predetermined angle, and a soft sheet of fabric with tensioning arms that wrap around the perimeter of the leg and frame to anchor the frame to the lower leg. Another example is the Exoform® Dorsal Night Splint sold by Ossur. That splint includes a soft attachment system and a metal plate within a plastic housing. The splint is bent by the patient into a pre-set L-shaped form, prior to application, with the splint retaining this pre-set angle during use. Another variation is disclosed in U.S. Pat. No. 7,682,325 to Chan, which includes a plate that has an accordion-like middle section and is bent into a pre-defined shape.
The frames used in the foregoing products and other similar technologies are cumbersome and are adjustable by the patent only before the frames are applied to the leg. If the splint does not fit properly, it must be removed before it can be adjusted, which takes more time and can lead to reduced patient compliance.
Some technologies have attempted to provide more adjustability to the device. One example is disclosed in U.S. Patent Application Publication No. 2009/0264803 of Darby et al., which includes a flexible frame with a toe strap used to elevate the patient's toes to relieve pain in the plantar fascia. That structure provides no ability for the patient to adjust the frame while positioned on the foot, and thus may not provide for a sufficiently deep stretch of the plantar fascia.
An improved system is needed to address these and other deficiencies, to achieve better fitting splints that can improve patient therapy and produce greater patient compliance.